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Completed

NCT Number: NCT04052178

Sensory Neuromodulation Protocol for the Treatment of Post-stroke Oropharyngeal Dysphagia.

Study design: Multicenter, experimental, randomized, crossed, double blind study (patient and results analysis).

Aim: To evaluate the effect of different neurostimulation techniques on the neurophysiological and biomechanical swallowing mechanisms of patients with dysphagia associated with chronic stroke and select those techniques with the best results to be evaluated in the second phase of the study (medium-term effects).

Outcome measures:

* Videofluoroscopy: prevalence of impaired efficacy and safety of swallow (penetrations and aspirations), penetration aspiration scale (PAS: from 0 to 8), biomechanical parameters (time to laryngeal vestibule closure, upper esophageal sphincter opening). * Pharyngeal sensory evoked potentials (pSEP): latency and amplitude of obtained evoked potentials. Higher latency (0 onwards) means worse outcome and higher amplitude (0 onwards) means better outcome. * Pharyngeal motor evoked potentials (pMEP): latency, amplitude, duration and area of obtained evoked potentials. Higher latency (0 onwards) means worse outcome and higher amplitude (0 onwards) means better outcome.

Treatments and patients: 36 post-stroke patients with oropharyngeal dysphagia (PAS superior or equal to 2) randomized patients in 3 treatment arms (3 groups of 12 patients).

* Active and sham repetitive transcranial magnetic stimulation (rTMS): 90% of the resting motor threshold, 1250 pulses, 5 Hz. * Active and sham Intrapharyngeal Electrical Stimulation (PES): 75% of tolerance threshold, pulses of 0.2 ms, 5 Hz, 10 min. * Oral Capsaicin (active intervention, 10-5M, TRPV1 agonist) and placebo solution (sham): 100 mL, single administration.

Administration of study therapies:

The study will be performed in two visits separated for one week. In each visit patients will randomly receive active or sham treatment and a pre-post evaluation of biomechanics of deglutition (with VFS) and neurophysiological mechanisms (swallowing afferent and efferent pathways) will be performed in each visit.

Acute randomized administration -> 1 active session (pre/post evaluation with VFS/pSEP/pMEP) + 1 separate control session 1 week apart (pre/post evaluation with VFS/pSEP/pMEP).

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Key information

Conditions

Swallowing Disorder Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Neurophysiologic Abnormality Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18 years.
  • Patients with a diagnosis of stroke of more than 3 months of evolution.
  • Patients with clinical signs of dysphagia according to the volume viscosity swallowing test (V-VST).
  • Patients capable of complying with the study protocol.
  • Explained study and signed informed consent.

Exclusion criteria

  • History of severe neurodegenerative, digestive diseases, epilepsy or previous seizures.
  • Pacemaker or implanted defibrillator carriers.
  • Implanted electrode carriers or other stimulation systems.
  • Implant carriers or metal plates on the head or neck.
  • Cochlear implant carriers.
  • Medication pump carriers.
  • History of hearing loss associated with noise.
  • Cardiopulmonary instability.
  • Oropharyngeal dysphagia of structural causes.
  • History of head and neck surgery.
  • Alcohol or drug dependence.
  • Pregnancy or breastfeeding.
  • Participate or have participated in another clinical interventionist trial in the 4 weeks prior to inclusion.

Treatment and study plan

rTMS active and sham

Device

Repetitive transcranial magnetic stimulation of the pharyngeal sensory cortex.

Other names: Repetitive transcranial magnetic stimulation

PES active and sham

Device

Intrapharyngeal electrical stimulation with a catheter delivering electrical pulses.

Other names: Intrapharyngeal electrical stimulation

Capsaicin active and placebo

Dietary Supplement

Capsaicin solution (TRPV1 agonist) at a concentration of 10-5M or placebo solution.

Other names: TRPV1 agonist (capsaicin at 10-5M) or placebo

Primary outcomes

  1. Pharyngeal motor evoked potential (pMEP): latency and amplitude

    Time frame: The event wil be assessed with pMEP immediately after the application of the intervention (time frame maximum up to 2 hours).

    Study the magnitude of the effect by calculating the change of the evoked potential from baseline immediately after the application of the intervention produced by the different treatments. This will be examined and compared between active and sham intervention.

  2. Pharyngeal sensory evoked potential (pSEP): latency and amplitude

    Time frame: The event wil be assessed with pSEPs immediately after the application of the intervention (time frame maximum up to 2 hours).

    Study the magnitude of the effect by calculating the change of the evoked potential from baseline immediately after the application of the intervention produced by the different treatments. This will be examined and compared between active and sham intervention.

  3. Penetration-aspiration scale (PAS) score

    Time frame: The event wil be assessed with the PAS score immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment).

    Study the magnitude of the effect by calculating the change on the prevalence of unsafe swallow (PAS≥2) in videofluoroscopy (VFS) from baseline immediately after the application of the intervention. This will be examined and compared between active and sham intervention.

Secondary outcomes

  1. Opening and closing time of the laryngeal vestibule

    Time frame: The event wil be assessed with VFS immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment).

    Time of the laryngeal vestibule opening and closure ranges from 0 to 1000 ms.

  2. Prevalence of pharyngeal residue

    Time frame: The event will be assessed with VFS immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment).

    The presence of pharyngeal residue in individual subjects will be assessed.

  3. Resting motor threshold (RMT) of the pharyngeal cortex

    Time frame: The event wil be assessed with TMS immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment).

    RMT is defined as the stimulation intensity in which the half of the stimuli are able to evoke a motor evoked potential of al least 10 uV of amplitude.

  4. Pharyngeal sensory thresholds

    Time frame: The event wil be assessed with pharyngeal electrical stimulation immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment).

    First perception and tolerance thresholds (from 0 to 100 mA) to electrical stimulation of the pharynx will be assessed by asking subjects the exact moment of first perception of the stimulus and the moment in which stimulation is not further tolerated, respectively.

  5. Incidence of Treatment-Emergent Adverse Events

    Time frame: Although its occurrence is early after the TMS session, seizures and other side effects will be monitored up to 3 months after the intervention.

    Seizures are the most feared side effect associated with transcranial magnetic stimulation (TMS). Seizures are a rare side event during and/or subsequent to a TMS session (1.4%, Bae et al., 2007) commonly not occurring beyond a few days after the last session. No other major or significant side effects are expected associated with the interventions.

Sponsors and collaborators

Lead sponsor

Hospital de Mataró

Other

Registry information

Official study title

Sensory Neuromodulation Protocol for the Treatment of Post-stroke Oropharyngeal Dysphagia. Short-term Neurophysiological Effects.

Acronym: FIS2014

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2019
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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